The present invention relates generally to medical and surgical devices and procedures, in which devices are temporarily or permanently implanted within the patient's body or are used for performing surgery on the patient's body, or are used for transporting blood and other fluids from or to the patient's body by means of catheters or other transporting devices. More particularly, the invention relates to disposable antiseptic wipes or impregnated pads which are packed within packages used for shipping and storing such medical and surgical devices.
Patients who undergo surgery of various kinds including implantation of devices such as catheters, leads, pacemakers, defibrillators, stents, and a wide variety of other devices or materials all to often suffer massive infection as a consequence of the use of aseptic materials. This occurs despite supplier packaging of the implantables or surgical tools in sterile packaging and the use of sterilizing radiation and the like, as well as the strict observation of aseptic requirements by the surgeons, nurses, and others involved in operating room procedures.
In this respect, it should be noted that surgical techniques have greatly improved during the last decade. Continuously collected knowledge and experience and standardization of operating methods has led to a dramatic reduction in risk of failure associated with even complex operations. In case of implantation of pacemakers, for example, increased knowledge and experience has led to a dramatic reduction in mortality, which at the present time ranges to 0.1% or even lower. Other problems such as functional problems have been reduced with an increased technical capability of the devices and enhanced electrode techniques. Therefore, the major problem that remains with implantation of medical interventional devices, such as cardiac pacemakers and defibrillators, is the risk of infections.
Several factors are associated with the infection of implantable devices, such as operation time, trauma to the tissue, the presence of a hematoma, presence of diabetes, increased age, and implantation of dual chamber devices. The reason for the increased number of infections with implantable cardiac pacemakers of dual chamber type is not simply the longer time required to perform the operation, which on average is only ten to fifteen minutes longer than that for a single chamber unit, but the increased number of foreign body biomaterials (biocompatible materials) that are part of the implanted device(s).
Recent studies have shown that these biomaterials, such as silicone or polyurethane, which are implanted in the human body, play a major part in the increased risk for infection. Recently gathered knowledge of the role of the polymer structure has led to a finding that microbiological germs such as staphylococcus epidermitis, or staphylococcus albus (as the same germ is also called), tend to settle preferentially on plastic material such as silicone or polyurethane insulation. The manner in which these germs nest on the surface is by quickly building a barrier of mucus, by which they become protected from any further action of systemically produced or introduced antibiotics. It has been found that the perioperative prophylaxis with a one-time antibiotic is helpful in reducing the number of infections. Nevertheless, there remain a number between 3% and 7% of devices for which infection occurs despite the use of great care by the implanting physician.
It is a principal aim of the present invention to provide means and methods by which to reduce the incidence and severity of infection in the course of or as a result of surgical or medical procedures, and to do so in a very simple, safe, and effective manner.